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Auditor Manager Medical Devices

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The company

Our client is a professional Medical Devices organisation, based in Antwerpen Belgium. This company is an international organisation that provides certifications for Life Sciences companies. As quality and regulations become more strict and complex, they are looking for some new employees.

Role description

In your position as technical manager, you will gain the responsibility to ensure the quality of the company’s auditors. On a daily basis, you will provide support to the auditors in the field. Furthermore, you will keep track of the developments within the Medical device market concerning quality and regulatory activities. You are the key person when it comes to guidance, coordination and insurance of technical qualifications for the auditors.

Responsibilities

On a daily basis, you will support the auditors with their projects. Furthermore, your responsibilities contain:
• Assess and improve technical qualifications of the staff members
• Achievement of company targets
• Scheduling and execute QMS audits for the medical devices sector according the company’s procedures
• Assessment of audit results and certification matters
• Create cohesion and collaboration within the organization
• Point of contact whenever there are issues with clients, notified bodies and other authorities

Requirements

On a daily basis, you will support the auditors with their projects. Furthermore, your responsibilities contain:
• Assess and improve technical qualifications of the staff members
• Achievement of company targets
• Scheduling and execute QMS audits for the medical devices sector according the company’s procedures
• Assessment of audit results and certification matters
• Create cohesion and collaboration within the organization
• Point of contact whenever there are issues with clients, notified bodies and other authorities

• Extensive experience with medical devices varying from class I to III
• Excellent knowledge of ISO 13485
• Great knowledge of relevant regulations from the European and international markets (such as FDA and CE- marking)
• Preferably experience as (Lead) auditor
• Excellent analytical and problem-solving skills
• Fluency in English, Dutch and business level French
• Strong in communication skills
• Excellent organizational and managerial skills
• Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders
• Bachelor or Master in Life Sciences
• Minimal 5 years of experience in the Medical Devices industry in both manufacturing and distribution environments

Other information

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.


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SIRE Life Sciences®

Ref. number: 45269
Listed by: SIRE Life Sciences®
Listed on: 11-07-2019
Country: Belgium
Region: Antwerpen
Employment: Permanent
Expertise: > 10 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4630

SIRE Engineering

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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